Clinical Intelligence

AbbVie’s Humira receives FDA approval for non-infectious intermediate, posterior and panuveitis

Tuesday, July 5, 2016

The FDA has approved AbbVie’s Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. Humira is now the first and only FDA-approved non-corticosteroid therapy available for adults with noninfectious intermediate, posterior and panuveitis. This approval marks the 10th approved indication for Humira in the U.S. for immune-mediated diseases.

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Shire’s retinopathy treatment fails phase II trial

Monday, July 4, 2016

Shire has announced that its phase II study evaluating an investigational protein replacement, SHP607, did not meet its primary endpoint of reducing the severity of retinopathy of prematurity (ROP), a rare eye condition. The study, however, demonstrated clinically relevant effects in secondary endpoints related to the development of severe bronchopulmonary dysplasia (BPD), a chronic lung disease, and severe intraventricular hemorrhage (IVH), a type of brain injury, both of which have lifelong negative implications for normal development. 

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NIH launches large study of pregnant women in areas affected by Zika virus

Tuesday, June 28, 2016

The National Institutes of Health and Fundacao Oswaldo Cruz-Fiocruz (Fiocruz), a national scientific research organization linked to the Brazilian Ministry of Health, have begun a multi-country study to evaluate the magnitude of health risks that Zika virus infection poses to pregnant women and their developing fetuses and infants. The study is opening in Puerto Rico and will expand to several locations in Brazil, Colombia and other areas that are experiencing active local transmission of the virus.

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